AUGUSTINE KUFFOUR
Oakland,RI
Summary
Dedicated Supervisor possessing skilled in addressing and resolving conflicts to maintain team harmony and performance. Offers 12 years of experience leading talented teams and exceeding objectives. Background includes strong history in Downstream Purification work.
Overview
12
12
years of professional experience
Work History
Supervisor Manufacturing
ReciBioPharm
Watertown, MA
02.2022 - 01.2024
- Trained and supervised 8 staff
- Led EMPQ execution at the Boxborough site
- Supervised Microme and Central Support Service team
- Authored, revise, review and approve cGMP documentation (OJTs and SOPs)
- Authored Deviations and CAPAs
- Approve timesheet and perform performance review
- Responsible for staff and team performance
- Ensured scheduling of production and maintenance activities
- Performed periodic review of cGMP documentation to ensure accuracy
- Initiated material onboarding form, order equipment and supplies from vendors
- Good use of equipment with KTF TFF, ONFAB, SUB and Anaerobic Chamber, Esco Isolator Chamber, Nanadrop, Sartorius Biosealer, Terumo and Sartorius Biowelder
- Efficient use of Veeva Vault
Senior Manufacturing Associate, Acting Supervisor
Rocket Pharmaceuticals
Cranbury, NJ
04.2020 - 02.2022
- Led equipment FAT, SAT, and facility start-up
- Led EMPQ execution.
- Authored, revised, reviewed, and approved cGMP documentation (batch records and SOPs)
- Trained and mentored staff. Assist in the development of staff process knowledge
- Experience with Manufacturing processes include but are not limited to cell line initiation (vial thaw), cell line scale-up, bioreactor operations, transfection, harvest clarification, TFF, column packing, chromatography and bulk drug substance fill
- Experience with AKTA ready flux, AKTA Ready process and AKTA ready, Nova Flex 2, Vi-Cell, Flow Star IV, Startocheck 4 and Startocheck 5 plus
- Perform periodic review of cGMP documentation to ensure accuracy.
- Accurately complete and compile official documentation per Rocket Good Documentation Practices (GDP) requirements
- Cross-trained on Upstream process
Senior Manufacturing Technician
Erytech Pharma, INC
Princeton, NJ
08.2019 - 03.2020
- Worked with Red Blood Cells Product
- Reviewed logbooks and Batch Records
- Able to demonstrate and apply good aseptic technique and cleanroom behavior
- Good gowning technique during certification, re-certification, and routine monitoring
- Ability to monitor all environmental parameters, such as viable and non-viable sampling, personnel sampling, and utilities following laboratory and company guidelines
- Perform required sampling utilizing contact plates, settling plates, RCS strips, and particle counters
- Perform environmental monitoring testing and utility sampling and testing on scheduled days
- Use of COBE and Erycaps machine
Lead Manufacturing Technician/Process Development
Outlook Therapeutics, INC
Cranbury, NJ
09.2018 - 08.2019
- Supervised and managed employees
- Revised SOPs, reviewed batch records and logbooks
- Performed daily weight check for raw material weighing and Dispensary
- Raw material sampling and Buffer preparation
- Protein purification process using buffer solutions, chromatography, viral filtration and concentration/diafiltration
- Used AKTA Avant in Process Development Lab for process characterization and optimization projects
- Good use of AKTAprocess skid for running process, sanitizing, WFI rinse and storage
- Good use of Millipore viresolve, depth filter, pH/Conductivity meter, Cubical Palletanks and Mixtainers
- SoloVPE SME
- Filled Bulk Drug Substance Aseptically
Senior Manufacturing Technologist
Immunomedics, INC
Morris Plains, NJ
05.2018 - 08.2018
- Led operations
- Manufactured antibodies, antibody fragments and conjugates
- Purified antibodies using ion-exchange, affinity column chromatography, and DV20 Virus Removal Filtration
- Maintained accurate batch records, logbooks, and log sheets
- Authored and revised batch records, buffer sheets, SOPs, and Material Specification Sheets (MSSs)
- Performed bulk drug substance
- Monitored and assured adequate supply of glassware/components for manufacturing
Senior Biologics Operator, Active Team Lead
Bristol Myers Squibb
East Syracuse, NY
01.2012 - 02.2018
- Distributed assignments, reviewed batch records and logbooks
- Yellow Belt certified and STOP certified
- Experience with trackwise, Delta V computer, AKTAprocess skid, high performance liquid chromatography, Fill Aseptic and Environmental Monitoring
- Performed buffer preparation, batch processing and sampling products
- Efficient use of conductivity, pH, and osmolality meters
- Product changeover of equipment
- Performed CIP and SIP buffer vessel, transfer lines and product tanks
- Performed phosphoric derouging, passivation integrity filter testing including planova
- Good use of Ultrafiltration, millipore viresolve and depth filter
- Operated parts washer and Autoclave
- Performed column conditioning, sanitization, WFI rinse and storage
- TOC Miscellaneous parts, system suitability & daily verification, total organic carbon analyzer
- Hot-Lips sealer, spectrophotometer, and SoloVPE expert
- LIMS and SAP
- Maintenance, 5S
Education
Bachelor of Science - Respiratory Therapy
SUNY Upstate Medical University
Syracuse, NY04-2011
Bachelor of Science - Biology
SUNY College At Oswego
Oswego, NY08-2008
Skills
- Process Improvement
- Strategic Planning
- Staff Management
- Operations Management
Accomplishments
- Dean’s list Fall 2009, Spring 2010, Fall 2010, Spring 2011 at SUNY Upstate Medical
- Taught Respiratory Care freshman laboratory clinical
- Maintained Merit or Honor Roll status throughout high school
- African Student Union President at SUNY Oswego
- Served as a school president on student government in Ghana
- Achieved High School National Society Award and selected to work in Career Center as a student assistant in senior year
Timeline
Supervisor Manufacturing
ReciBioPharm
02.2022 - 01.2024
Senior Manufacturing Associate, Acting Supervisor
Rocket Pharmaceuticals
04.2020 - 02.2022
Senior Manufacturing Technician
Erytech Pharma, INC
08.2019 - 03.2020
Lead Manufacturing Technician/Process Development
Outlook Therapeutics, INC
09.2018 - 08.2019
Senior Manufacturing Technologist
Immunomedics, INC
05.2018 - 08.2018
Senior Biologics Operator, Active Team Lead
Bristol Myers Squibb
01.2012 - 02.2018
Bachelor of Science - Respiratory Therapy
SUNY Upstate Medical University
Bachelor of Science - Biology
SUNY College At Oswego
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